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WILMINGTON, Del. & PRINCETON, N.J.

Public Company Information:

NYSE:

BMY

NYSE:

AZN

WILMINGTON, Del. & PRINCETON, N.J.--(BUSINESS WIRE)--AstraZeneca
(NYSE:AZN) and Bristol-Myers
Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug
Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory
Committee (EMDAC) voted 13-1 that the benefits of dapagliflozin use
outweigh identified risks and support marketing of dapagliflozin as an
adjunct to diet and exercise to improve glycemic control in adults with
type 2 diabetes mellitus. The Advisory Committee also voted 10-4 that
the data provided sufficient evidence that dapagliflozin, relative to
comparators, has an acceptable cardiovascular risk profile.

The FDA is not bound by the Advisory Committee’s recommendation but
takes its advice into consideration when reviewing the application for
an investigational agent. The Prescription Drug User Fee Act (PDUFA)
goal date for dapagliflozin is Jan. 11, 2014.

Dapagliflozin is being reviewed by the FDA for use as monotherapy, and
in combination with other antidiabetic agents, as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes. It
is a selective and reversible inhibitor of sodium-glucose cotransporter
2 (SGLT2) that works independently of insulin to help remove excess
glucose from the body. Dapagliflozin, an investigational compound in the
U.S., was the first SGLT2 inhibitor to be approved anywhere in the
world. Dapagliflozin is currently approved under the trade name
[Forxiga]™ for the treatment of adults with type 2 diabetes, along with
diet and exercise, in 38 countries, including the European Union and
Australia.

The EMDAC was provided with data from the extensive dapagliflozin global
clinical development program included as part of the New Drug
Application (NDA) and resubmission. In response to the FDA’s Jan. 2012
complete response letter, the NDA resubmission included several new
studies and additional long-term data (up to four years’ duration) from
previously submitted studies, resulting in an overall increase in
patient-years exposure to dapagliflozin of more than 50 percent as
compared to exposure in the original NDA. The resubmission included data
from the dapagliflozin Phase II/III clinical development program, which
included more than 11,000 adult patients with diabetes (approximately
6,000 patients received dapagliflozin) in 24 clinical trials.

Patient populations examined covered the range of diabetes progression,
including drug-naïve patients, patients inadequately controlled on oral
therapies and patients on insulin-based regimens. The program also
provided significant experience in elderly patients, patients with a
history of cardiovascular (CV) disease, overweight and obese patients,
patients with poorly controlled hypertension and patients with mild to
moderate renal impairment. In accordance with FDA guidelines, the NDA
resubmission also included data assessing the CV safety of dapagliflozin
in adults with type 2 diabetes. Additionally, the DECLARE study is being
conducted in patients with type 2 diabetes to determine the effect of
dapagliflozin, when added to the patients’ current anti-diabetes
therapy, on the risk of CV events, such as CV death, myocardial
infarction or ischemic stroke, compared with placebo. The randomized,
double-blind, placebo-controlled study of more than 17,000 patients
initiated enrollment in April 2013 and has an anticipated completion
date of 2019.

About Type 2 Diabetes

Diabetes is estimated to affect 26 million people in the U.S. and more
than 382 million people worldwide. The prevalence of diabetes is
projected to reach more than 592 million people worldwide by 2035. Type
2 diabetes accounts for approximately 90-95 percent of all cases of
diagnosed diabetes. Type 2 diabetes is a chronic disease characterized
by several pathophysiologic defects, including insulin resistance and
dysfunction of pancreatic beta cells, leading to elevated glucose
levels. Over time, this sustained hyperglycemia contributes to further
progression of the disease. Significant unmet needs still exist, as many
patients remain inadequately controlled on their current
glucose-lowering regimen.

About SGLT2 Inhibition

The kidney plays an important role in maintaining normal glucose
balance, in part by filtering and subsequently reabsorbing glucose back
into circulation. SGLT2, a sodium-glucose cotransporter found
predominantly in the kidney, is responsible for the majority of glucose
reabsorption in the kidneys. In patients with type 2 diabetes, the
capacity of the kidney to reabsorb glucose is increased by approximately
20-30 percent, further exacerbating the hyperglycemia associated with
the disease. Selective inhibition of SGLT2 reduces the reabsorption of
excess glucose and enables its removal via the urine.

About the AstraZeneca/Bristol-Myers Squibb Diabetes Alliance

Dedicated to addressing the global burden of diabetes by advancing
individualized patient care, AstraZeneca and Bristol-Myers Squibb are
working in collaboration to develop and commercialize a versatile
portfolio of innovative treatment options for diabetes and related
metabolic disorders that aim to provide treatment effects beyond glucose
control. Find out more about the Alliance and our commitment to meeting
the needs of health care professionals and people with diabetes at www.astrazeneca.com
or www.bms.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of cardiovascular,
metabolic, respiratory, inflammation, autoimmune, oncology, infection
and neuroscience diseases. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
For more information please visit: www.astrazeneca.com.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to discover, develop and deliver innovative medicines that help
patients prevail over serious diseases. For more information about
Bristol-Myers Squibb, visit www.bms.com
or follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding product development. Such forward-looking statements are based
on current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and
could cause actual outcomes and results to differ materially from
current expectations. No forward-looking statement can be guaranteed.
Among other risks, there can be no guarantee that dapagliflozin will
receive regulatory approval in the U.S. or, if approved, that it will
become a commercially successful product. There is also no guarantee
that the FDA will make a regulatory decision within the time frame
described in this release. Forward-looking statements in this press
release should be evaluated together with the many uncertainties that
affect Bristol-Myers Squibb's business, particularly those identified in
the cautionary factors discussion in Bristol-Myers Squibb's Annual
Report on Form 10-K for the year ended December 31, 2012, in our
Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K.
Bristol-Myers Squibb undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.